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Acino CMO specific technology capabilities
Acino International
Drug Product : Small Molecules

For many decades, Acino has been mastering the manufacturing of pharmaceuticals and gained in-depth knowledge in the processing of oral solid dosage forms (granulate, pellets, tablets & capsules). This poster provides an overview of the specific Acino CMO technology capabilities for oral solid dosage forms and services.

Keywords: Acino CMO specific technology capabilities for OSD

Alina Simonenko
alina.simonenko@acino.swiss

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Application of MVDA, Raman Spectroscopy and Process Control to enhance bioprocess understanding
APC Ltd.
Drug Substance : Biologics

Chinese Hamster Ovary cells are the most widely-used platform for the production of monoclonal antibodies (mAbs) by the biopharmaceutical sector. CHO cell mAb manufacturing processes require refinement to ensure that the highest product yield is achieved while ensuring quality. The use of Process Analytical Technology (PAT), such as Raman spectroscopy, enables in-depth interrogation of cell culture operations in order to define optimal feeding and control strategies.

Keywords: MVDA, Raman Spectroscopy, Process Control, Process Development

David Crowley
david.crowley@approcess.com

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Innovation in Flow Chemistry for Accelerating the Critical Path to First-in-Human Trials
Arcinova
Drug Substance : Small Molecules

There is an urgent market need for an integrated drug substance / drug product offering using one site and with an intensive technology focus. The new Arcinova model ensures secure delivery of technically complex projects with a focus on velocity and scalability. Rapid delivery of materials to Biotech clients is a key differentiator and aligns with the Biotech fundraising model, which is highly focused on clinical deliverables and payment milestones.

Keywords: Innovation, Flow Technology, Drug Substance, Drug Product, Scalability, Biotech

Paul Quigley
Paul.Quigley@arcinova.com

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Ardena services
Ardena
Discovery : Small Molecules

Ardena offers an integrated, flexible service encompassing drug substance production, dosage form manufacture, clinical logistics, bioanalysis and dossier development. We are also at the leading edge of nanomedicine development. Our precision particle engineering and characterisation technologies are the key to accessing this fast evolving, competitive market.

Keywords: Drug Substance, Drug Product, Solid State Research, API, Nanomedicines, Clinical Supply, Bioanlysis, Regulatory Dossier Development

Joren De Koning
joren.dekoning@ardena.com

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Continuous Production of Anhydrous tert-Butyl Hydroperoxide in Nonane Using Membrane Pervaporation and Its Application in Flow Oxidation of a γ-Butyrolactam
Asymchem Laboratories (Tianjin) Co Ltd
Drug Substance : Small Molecules

Anhydrous tert-butyl hydroperoxide (TBHP) is a powerful oxidizing agent in many chemical transformations. Despite its versatility, the use of anhydrous TBHP has been greatly limited because of safety concerns, particularly on a production scale. We describe a membrane pervaporation method that allows the production of anhydrous TBHP solution in continuous manner. The system consists of membrane modules in series that are made of perfluorinated polymer, allowing it to remove water efficiently.

Keywords: Flow chemistry, Membrane pervaporation, Oxidation, Continuous process, Continuous extraction, Diastereoselective synthesis, Continuous concentration, End-to-end, Power Of Flow

Jordi Robinson
JordiRobinson@asymchem.com

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Biotech Outsourcing Strategies Events Poster
Bio2Business Ltd
Discovery : Small Molecules

BOS Events Overview

Keywords: Conference, Exhibition, Outsourcing, Manufacturing, Discovery, Partnering

Richard Collins
richard.collins@bio2business.com
Locating and understanding hydrated forms of an API
Cambrex
Drug Substance : Small Molecules

Facile hydrate formation can drastically alter the processability, stability and aqueous solubility of a given API. Cambrex Edinburgh was able to fully characterize and develop a reliable method for avoiding the hemi-hydrated form of an API that was discovered during a polymorph screening project.

Keywords:




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Capture Compound Mass Spectrometry®: on- and off-target deconvolution
Charles River
Discovery : Small Molecules

Capture Compound Mass Spectrometry(CCMS) is an unbiased, proteome-wide approach for the identification of specific-binding protein targets for small molecules and peptides. The technology combines medicinal chemistry and in vitro pharmacology, coupled to high resolution proteomics mass spectrometry to isolate and identify target proteins that are responsible for an observed biological response. This technology can be used in a variety of contexts from target de-convolution and drug re-purposing.

Keywords: target, deconvolution, toxicity

Tammy Ladduwahetty
Tammy.Ladduwahetty@crl.com

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INOFEA Poster BOS 2019
INOFEA AG
Discovery : Other



Keywords: empowered enzymes, bioanalysis, bioconjugation, biocatalysis

Dr. Yves Dudal
yves.dudal@inofea.com

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This is not just fill finish: insight from a C(D)MO perspective
Legacy Pharmaceuticals Switzerland GmbH
Drug Product : Biologics

After a long and expensive process to develop DS, biotech companies want to quickly move to First-in-Human. The added value of Fill Finish is often regarded as a simple development step, but it is actually extremely complex in nature. Not enough time for Fill Finish partners selection and technology transfer is usually planned, as well as for primary packaging selection. The establishment of a strong Fill Finish partners network early in the process could save time and money in DP developments.

Keywords: sterile aseptic fill finish contract manufacturing

Carole Delauney
cdelauney@legacypharm.com

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Development of an early wound model in human ex vivo skin explant as a preclinical model of wound healing
MedPharm
Discovery : Small Molecules

This assay has the potential to be used as an early screening tool for drug selection and topical formulation optimisation for NCE and generic medicine development for the advanced healing of wounded skin. Whether targeting keratinocyte proliferation and differentiation, modulation of inflammatory response, or collagen and fibroblast remodeling, this model has the potential for proof of concept research in the dermatological advancement of topical wound therapies.

Keywords: Wound Healing, Model, Ex Vivo, Skin, Pre-Clinical

Daniel Morland
busdev@medpharm.com

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The development of a set of novel small molecule inhibitors of the Kv1.3 ion channel
Metrion Biosciences
Discovery : Small Molecules

Ion channels represent 15-20% of historic drug approvals but are notoriously complex targets and require specialised screening technology such as automated patch clamp (APC) electrophysiology. We outline a situation where a pharma company turns to a specialist CRO to fill their knowledge gap. During the collaboration, we developed potent and selective Kv1.3 modulators with nM efficacy against human T-cells and potential to treat auto-immune disease.

Keywords: small molecules; ion channels; potassium channels; drug discovery; auto-immune disease

Sophie Rose
sophie.rose@metrionbiosciences.com

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CESS for the Production of Nanoparticles
Nanoform Finland
Drug Substance : Small Molecules

The patented CESS technology is based on supercritical CO2. The drug solution is expanded through a controlled process to produce pure drug nanoparticles. In this poster we show our nanonisation approach and a few case studies of nanoparticle production for tuning the particle size of APIs.

Keywords: Nanoparticles, nanonisation

Niklas Sandler
niklas.sandler@nanoform.fi

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Demand for Biotech packaging drives significant PCI investment at multiple locations world wide
PCI Pharma Services
Drug Product : Other

PCI recognise that biologically derived therapeutic products are the new frontier, heralding revolutionary treatments of a number of diseases and injuries. We have committed to a $20m investment in support of biologic medicines and advanced injectable delivery forms. Expanding our Biotech clinical and commercial packaging and release testing capability at our Centre of Excellence in Philadelphia, as well as expanded Cold Chain capacity at numerous global locations.

Keywords: Biologics, High Potent, development, clinical, manufacturing, packaging, ultra cold chain

Joanne Phelps
joanne.phelps@pciservices.com

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Continuous technology improvement: key partnership to meet your outsourcing needs
Procos SpA
Drug Substance : Small Molecules

Procos S.p.A. is a CDMO focused to the development, scale-up and manufacturing of Active Pharmaceutical Ingredients (API’s) and has continuously expanded its technology portfolio in the last ten years in order to match customer needs. The approaches are mainly through business opportunity and customer partnership. Reported as showcases, the recent expansion into High Potent API to respond to the current market needs and the flow chemistry implementation, requested by an established customer.

Keywords: HPAPI, Flow Chemistry, API, Small Molecules

Simone Manzini
manzini@procos.it

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Digitalisation of Research Outsourcing
scientist.com
Discovery : Other

Digitalisation of business processes and drug development is a trend that will not be going away anytime soon. Scientist.com are supporting the worlds best pharma and Biotech companies to digitalise their research outsourcing processes. Creating faster science by: - Giving science time back to researchers - Removing legal delays - Accessing global innovation Real life case studies and data provide a compelling argument to transform research outsourcing.

Keywords: Outsourcing, Digitalisation, Pre-clinical, toxicology, HBS, Human Samples, Faster Science, Protein, Antibodies, Speed, Pharma, Biotech, HEOR, RWE

Tom Dexter
tom@scientist.com

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Diazomethane: embracing hazardous chemistry at scale and through the utilisation of flow technology
Sterling Pharma Solutions Ltd
Drug Substance : Small Molecules

Dr Dan Stark will be presenting Sterling Pharma Solutions capabilities for the scale-up and manufacture of complex and hazardous synthesis. Showcased through Sterling’s current work on diazomethane and the utilisation of modern flow chemistry technologies in API manufacture.

Keywords: Diazomethane

Dr Dan Stark
daniel.stark@sterlingpsl.com

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Development and Scale up of continuous flow processes for the manufacture of API
Thermo Fisher Scientific
Drug Substance : Small Molecules



Keywords: APi, flow chemistry, continuous process

Peter Poechlauer
peter.poechlauer@thermofisher.com

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Click here to view BOS cmc 2018 poster submissions.